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Efficacy of a Combined Linguistic/Communication Therapy in Acute Aphasia After Stroke (ORACLE)

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ClinicalTrials.gov Identifier: NCT03287544
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.

Condition or disease Intervention/treatment Phase
Aphasia, Acquired Other: Combined rehabilitation Other: Linguistic rehabilitation Not Applicable

Detailed Description:

Twenty to 25% of strokes cause aphasia. Speech and language therapy is the well-known standard treatment of aphasia after stroke although it is based on weak scientific evidence. To date, the efficacy criteria of aphasia rehabilitation are early stage, intensity as well as personalized treatment. Usually these patients receive in acute phase a linguistic training focused on the linguistic impairment. This approach is based on the cerebral plasticity postulate. However the superiority of this practice compared to other methods has never been shown. Moreover the benefit of the combination gathering linguistic treatment with communication treatment has to our knowledge never been studied.

In the present study investigators propose to compare the effect of a combined linguistic/communication rehabilitation versus a linguistic treatment. To do so, investigators will recruit patients with aphasia after a first stroke, in the acute phase. After a allocation to the " combined " and " linguistic " groups, all the patients will have a comprehensive language and neuropsychological assessment before and after 3 months of rehabilitation, and finally 6 months after the onset.

The "linguistic" group will have a rehabilitation only focused on linguistic processes whereas the "combined" group will have a linguistic training as well as communication training. The therapy will be personalized and the therapists will exclusively use standardized linguistic and/or communication toolboxes of rehabilitation containing dedicated activities.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

There are two arms in the protocol: one experimental arm corresponding to the "combined" rehabilitation (linguistic/communication) compared with another arm corresponding to the "linguistic" rehabilitation.

All included patients, after allocation based on aphasia severity to the " combined " and " linguistic " groups, will have a first evaluation (E1: language, neurologic and neuropsychological exams) within 7 days after the onset. Then after a 3 months rehabilitation period they will be assessed (E2: language, neurologic and neuropsychological exams). At 6 months after the onset they will finally have the last assessment (E3: language, neurologic and neuropsychological exams).

Masking: Single (Outcomes Assessor)
Masking Description: After the allocation in the groups, rehabilitation is not done blindly since the speech therapist knows what activities he offers to patients. However, the evaluations carried out by a speech therapist, are done without the knowledge of the rehabilitation group.
Primary Purpose: Supportive Care
Official Title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined rehabilitation
Linguistic training as well as communication training.
Other: Combined rehabilitation
Linguistic training as well as communication training.

Active Comparator: Linguistic rehabilitation
Rehabilitation only focused on linguistic processes.
Other: Linguistic rehabilitation
Rehabilitation only focused on linguistic processes.




Primary Outcome Measures :
  1. Assessment of the communication performance. [ Time Frame: Month 3 ]
    Assessed by the Lillois communication test


Secondary Outcome Measures :
  1. Assessment of the communication performance. [ Time Frame: Month 6 ]
    Assessed by the Lillois communication test

  2. Assessment of the linguistic performance. [ Time Frame: Month 3; Month 6 ]
    Assessed by the "Score at understanding task".

  3. Assessment of the quality of life. [ Time Frame: Month 3; Month 6 ]
    Assessed by the "Score at a specific quality of life scale ".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First stroke
  • Inclusion at the acute phase (< 7 days)
  • Patient registered at the social security system
  • French as usual language
  • Aphasia severity score measured by the Boston Diagnostic Aphasia Examination (BDAE) scale ≥ 1 and ≤ 4
  • Consent signed by the patient or if not, by the caregiver

Exclusion Criteria:

  • Cognitive impairment before the onset (IQCode > 3.4)
  • Alcohol or drug addiction
  • Untreated psychiatric disease,
  • Uncorrected sensory impairment
  • Evolutive pathology
  • Adults protected by Law
  • Participation to another research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287544


Contacts
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Contact: Lola Danet, PhD 5 61 77 95 17 ext 33 danet.l@chu-toulouse.fr
Contact: Stéphanie Delrutte, PhD 5 61 77 56 13 ext 33 delrutte.s@chu-toulouse.fr

Locations
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France
Hôpital Pierre Paul Riquet Recruiting
Toulouse, Midi-Pyrénées, France, 31059
Contact: Lola Danet, PhD    5 61 77 95 17 ext 33    danet.l@chu-toulouse.fr   
Contact: Stéphanie Delrutte    5 61 77 56 13 ext 33    delrutte.s@chu-toulouse.fr   
Principal Investigator: Lola Danet, PhD         
Sub-Investigator: Stéphanie Delrutte         
Sub-Investigator: Eila Rodilla-Lange         
Sub-Investigator: Séverine Bodin         
Sub-Investigator: Catherine Bezy         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Lola Danet, Phd University Hospital, Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03287544     History of Changes
Other Study ID Numbers: RC31/16/0018
2017-A02163-50 ( Other Identifier: ID-RCB )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Aphasia
Rehabilitation
Communication
Linguistics

Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms